White Paper

De-Risking Biosimilar Development With A Clinically Validated & Commercially Proven Disposable Autoinjector

By Victoria Meyer, MBA, BD

BD2

As biosimilar development continues to accelerate with nearly $112 billion in biologic medicines set to lose exclusivity in the global market by 2025, the market is becoming increasingly competitive, putting first-to-market biopharmaceutical companies at a key advantage.1 With current timelines for biosimilar development and review from health authorities estimated to be nearly 7 years at a cost of between $100 and $300 million to develop, delays during combination product development and regulatory approvals can impact launch timelines and potential market penetration.2,3 A fundamental area in which biopharmaceutical companies can de-risk the launch process is by choosing a suitable autoinjector technology and partner.

Anticipating and retiring inherent risks in biosimilar development is one of the most essential tasks to be undertaken by companies seeking coveted first-mover status. And yet, the development and commercialization of biologic combination products to treat chronic conditions entails highly complex and challenging processes. Stringent performance requirements, together with increasing regulatory demands and intense competition, contribute to the complexity. Certain factors will be essential in establishing and maintaining an early lead. These include evaluation and selection of suitable combination product technology, and the selection of a combination product development partner with proven commercial solutions, complementary capabilities, and the expertise to positively address those complexities. A solution and partner that can help biopharmaceutical companies manage costs will be essential to achieve commercial success in a market that will only become more competitive. For many biopharmaceutical customers, BD and the BD Physioject™ Disposable Autoinjector have offered the appropriate combination of technology, documentation, and resources required for timely success.4

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